U.S. patent application number 10/169825 was filed with the patent office on 2003-05-15 for medication monitoring device.
Invention is credited to Abita, Joseph L, Cain, Russell P, Carkhuff, Bliss G.
Application Number | 20030089733 10/169825 |
Document ID | / |
Family ID | 22617327 |
Filed Date | 2003-05-15 |
United States Patent
Application |
20030089733 |
Kind Code |
A1 |
Cain, Russell P ; et
al. |
May 15, 2003 |
Medication monitoring device
Abstract
A medication compliance monitor applicable to common approved
dispensing containers is not apparent to a user patient. The
monitor device applies to a container with a coil positioned
thereabouts, uses a container top/cap including a metal material;
and collects data with an electronic circuit operatively connected
to the coil and housed in a housing coupled to the bottom of the
container The device utilizes a medically approved common
dispensing container; the typical medication label covers the coil
and electronics.
Inventors: |
Cain, Russell P; (Columbia,
MD) ; Carkhuff, Bliss G; (Laurel, MD) ; Abita,
Joseph L; (Boyds, MD) |
Correspondence
Address: |
Ernest R Graf
The Johns Hopkins University
Applied Physics Laboratory
11100 Johns Hopkins Road
Laurel
MD
20723-6099
US
|
Family ID: |
22617327 |
Appl. No.: |
10/169825 |
Filed: |
July 9, 2002 |
PCT Filed: |
November 14, 2001 |
PCT NO: |
PCT/US01/43656 |
Current U.S.
Class: |
222/30 ;
222/23 |
Current CPC
Class: |
A61J 7/0436 20150501;
A61J 7/0481 20130101; A61J 7/0418 20150501 |
Class at
Publication: |
222/30 ;
222/23 |
International
Class: |
B67D 005/06; B67D
005/38; B67D 005/24 |
Claims
1. A dispensing monitor device comprising: a container including a
body having a bottom portion; a coil positioned about the body of
the container; a top positionable on the container and including a
metal material; an electronics housing operatively coupled to the
bottom portion of the container; and an electrical circuit housed
by the electronics housing and operatively connected to the
coil.
2. A dispensing and monitoring device according to claim 1, wherein
the electrical circuit comprises: a computer operatively coupled to
the coil; a clock; and a memory.
3. A dispensing and monitoring device according to claim 2, wherein
the computer includes the clock and a memory for storing a
program.
4. A dispensing and monitoring device according to claim 2, wherein
the coil has a first inductance when the cap is positioned on the
container and a second inductance when the cap is not positioned on
the container.
5. A dispensing monitor device according to claim 2, further
comprising means for communicating data operatively connected to
the computer.
6. A dispensing and monitoring device according to claim 5, wherein
the means for communicating comprises an electric connection for
connecting to an adapter.
7. A dispensing and monitoring device according to claim 5, wherein
the means for communicating comprises an induction coil.
Description
BACKGROUND OF THE INVENTION
[0001] The present invention relates to drug dispensing apparatus,
and more particularly to a device for monitoring patient compliance
with drug therapy. Patient compliance is a major factor affecting
the efficacy of drug therapy. Prior attempts at developing combined
drug dispensing and monitoring devices resulted in relatively bulky
and expensive packages. Moreover, these devices did not employ Food
and Drug Administration approved containers. One such device is
discussed in M. A. Kass et al., "A Miniature Compliance Monitor for
Eyedrop Medication," Arch. Opthalmol., 102, 1500-1554 (1984). This
device did not employ an approved Food and Drug Administration
container, and it is not available commercially.
[0002] Physicians are typically interested in both the amount of a
drug dispensed by a patient, as well as the time and date that the
drug was dispensed by the patient. This is particularly useful in
clinical trials of a drug. It is important that the patient not be
aware of monitoring of drug dispensing. This is because patients
may be inclined to change their routines if they were aware of the
monitoring process. Consequently, it is useful to have a drug
dispensing device that can monitor patient use of the medication
without having the patient aware of the monitoring activity. The
data collected by the device does not necessarily need to include
the amount of medication dispensed by the patient. This is because
the time and date that the patient administered the drug is often
more important than the amount of medication dispensed by the
patient. Accordingly, there is a need for a simple, low cost drug
dispensing device that provides physicians with such time and date
information. However, knowing the time and date information can
indirectly infer the amount of medication in cases in which the
applicator provides for dispensing a metered quantity of medicine,
as is the case for prescription eye medication.
SUMMARY OF INVENTION
[0003] It is an object of the present invention to provide a
simple, low cost drug dispensing monitor device that tracks the
time and date that a drug is dispensed.
[0004] It is a further object of the present invention to provide
an objective measure of drug dispensing compliance.
[0005] It is another object of the present invention to provide a
drug dispensing monitor device that is compatible with Food and
Drug Administration approved drug-dispensing containers.
[0006] It is still a further object of the present invention to
provide a device that monitors and records the date and time that a
drug is applied and stores this information for subsequent readout
and analysis.
[0007] It is still another object of the present invention to
provide dispensing monitor device wherein the monitoring
electronics and sensors are not visible to a user patient, and the
shape of the dispensing container does not reveal their attached
presence.
[0008] It is a further object of the present invention to provide a
low-power dispensing monitor device capable of recording the time
and date that a drug is dispensed.
[0009] It is still another object of the present invention to
provide a reusable dispensing monitor device.
[0010] To achieve the above and other objects, the present
invention provides, a dispensing monitor device that comprises: a
container that includes a body having a bottom portion; a coil
positioned about the body of the container; a top positionable on
the container and including a metal and/or magnetic material; an
electronics housing operatively coupled to the bottom portion of
the container; and an electrical circuit housed by the electronics
housing and operatively connected to the coil.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 is an exploded view of an embodiment of the
invention.
[0012] FIG. 2 is an assembled view of the embodiment shown in FIG.
1.
[0013] FIG. 3 is a schematic cutaway view of an embodiment of the
invention.
[0014] FIG. 4 is a schematic block diagram of an example of an
electrical circuit in an embodiment of the invention.
[0015] FIG. 5 is a flow diagram of software for an exemplary
embodiment of the invention.
[0016] FIG. 6 is an exemplary layout of the electrical components
in an embodiment of the invention.
[0017] FIG. 7 is an example of adapter connections in an embodiment
of the invention.
[0018] FIG. 8 is an example of adapter cabling in an embodiment of
the invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0019] FIG. 1 is an exploded view of an embodiment of the
invention. FIG. 1 shows a standard Food and Drug Administration
(FDA) approved container 5. The container 5 has a body 10 and a
bottom portion 15. In the preferred embodiment, a coil 20 is
positioned around the body 10. The coil 20 comprises a variable
reluctance sensor. In a preferred embodiment of the invention, the
top or cap 25 of a standard container has only a slight,
inconspicuous modification. In one approach caps would be modified
as supplied by the provider; in another approach a standard
unmodified cap would be removed and the physician would replace it
with a sterile modified cap. In still another embodiment, a
conformal cap can be inconspicuously attached to the standard cap
of the provider thus affecting no modifications to the medicinal
dispenser as provided. The cap modification does not interfere with
or adversely affect the safety seal normally positioned around the
container/cap interface nor does it impact the approved condition
of the medication. In one embodiment, the cap 25 can include a
magnetic or metal portion. The metal portion can be plated,
embedded, or affixed to the cap 25. The presence of the metal near
the coil 20 changes the electrical properties of the coil 20.
Alternatively the cap 25 can include any other material that
changes the inductance of the coil 20. Thus, the coil 20 has a
first inductance when the cap 25 is on the container 10 and a
second inductance when the cap 25 is not on (has been removed from)
the container 10.
[0020] An electronics housing 30 is adjoined to the bottom portion
15 of the container 5 as shown in FIG. 1. A pair of thin leads 32
connects the coil 20 to an electrical circuit (described below)
housed in the electronics housing 30. The leads 32 can comprise,
for example, adhesive metallized Kapton.
[0021] FIG. 2 is an assembled view of the embodiment shown in FIG.
1. The coil 20 slides over the body 10 of the container 5. Normally
standard containers such as container 10 are translucent. So, as
shown in FIG. 2, a label 35 conceals and renders the coil 20
unnoticeable to a user. The label 35 can also conceal the
electronics housing 30. The label 35 can also function to hold the
coil 20 and leads 32 in place and, if desired, can assist in
holding the electronics housing 30 in place. Since the label 35
conceals the coil 20, leads 32 and electronics housing 30, the user
of a dispenser in accordance with the present invention is unaware
of the electronic nature of the container.
[0022] FIG. 3 is a schematic cutaway view of an embodiment of the
invention. In FIG. 3, cap 25 includes a magnet 27 having an
associated magnetic field (B-field) 28. The B-field 28 interacts
with the coil 20. Removing the cap 25 causes coil 20 to sense
movement of the B-field, and thus removal of the cap 25. FIG. 3
also schematically shows a fluid 37 to be dispensed. As with the
embodiment shown in FIG. 2, the FIG. 3 embodiment includes a label
35 that protects and hides the coil 20 from the user. As discussed
below, embodiments of the present invention can include a tilt
sensor 54 shown in FIG. 3. A battery or batteries 170 shown in FIG.
3 provide power for the electronics housed in, for example, a
module 42. An interface 75 provides an electrical connection to the
electronics. The interface could also be, for example, a radio
frequency (rf) interface or an infrared interface. The particular
interface chosen depends upon the application for the present
invention.
[0023] FIG. 4 is a schematic block diagram of an example of an
electrical circuit 40 in an embodiment of the invention. Referring
to FIG. 4, the system includes a microcontroller 45. In a preferred
embodiment of the present invention, the microcontroller 45 can
comprise any microcontroller or microprocessor. To reduce power, it
is desirable to use a device with low power requirements. One
example of the many available microcontrollers is an 8-bit
microcontroller, PIC16C67, manufactured by Microchip Technology,
Inc. The microcontroller 45 used in the preferred embodiment
includes 2 Kbytes of electrically programmable read only memory. It
is also small, approximately 7.9 mm.times.10.33 mm. For the
embodiment of the invention the low power consumption aids in
providing a long lifetime for the dispenser. The microcontroller
consumes a maximum of 48 .mu.A at 3.0 volts. The microcontroller
has a power down or sleep mode in which the power consumption falls
to only 5 .mu.A at 3.0 volts. Contacts 50 connect to the leads 32
to electrically couple the coil 20 to the microcontroller 45. It
will be appreciated to those skilled in the art that there are a
wide variety of other devices that can be used to practice the
present invention. This discussion of a specific microcontroller is
merely for illustration. Those skilled in the art will recognize
that the present invention is not limited to any particular
microcontroller or microprocessor. The selection of a
microcontroller or microprocessor to practice the present invention
depends upon the design of the particular application.
[0024] The electrical circuit 40 also includes a real time clock
55. In a preferred embodiment of the present invention, the real
time clock 55 can comprise any real time clock. It need not be a
separate device; it can be included on the microcontroller 45. An
example of one of the many available real time clocks is part
number DS-1302 manufactured by Dallas Semiconductor, Inc. In the
exemplary embodiment shown in FIG. 4, a 32.768 kHz crystal 58
drives the real time clock 55. The real time clock 55 can function
as both a clock and calendar. The calendar has leap year
compensation. The date and time are stored as binary-coded decimal
(BCD) values in seven internal registers that record month, day,
hour, and minute. The time and date data in the internal registers
can be stored in an electrically erasable programmable read only
memory (EEPROM) 60. Any EEPROM can be used with the present
invention. One example or the may available EEPROMs is part number
24AA04 manufactured by Microchip Technology, Inc. As will be
understood by those skilled in the art, the present invention is
not limited to any particular EEPROM device. The selection of an
EEPROM device depends upon the requirements of a particular
application. Both the real time clock 55 and the memory 60
communicate with the microcontroller 45 through a two-wire serial
Inter-Integrated Circuit (I.sup.2C) bus 65. The real time clock has
a control line 70 that enables the real time clock external
interface. When the line 70 is low, the real time clock keeps time,
but draws only about 1 .mu.watt of power.
[0025] The memory 60 stores the date and time values obtained from
the real time clock 55. In an exemplary embodiment of the present
invention, the memory 60 includes 4 Kbytes of memory, and
communicates with the computer over the bus 65. Storing the date
and time data in an EEPROM ensures that if there is a loss of
power, data will be retained. Also, the communication of the memory
60 and microcontroller 45 make it difficult for a user to tamper
with the data. Moreover, the cells of the EEPROM are typically
capable of one million read/write operations. This far exceeds the
expected lifetime of a dispenser in accordance with the
invention.
[0026] The electrical circuit 40 can provide the collected data via
an interface 75 discussed below. The microcontroller 45 includes a
communication interface 80, such as a UART to provide the desired
data to the interface 75. The interface can be a standard RS-232
interface. The RS-232 drive electronics can be housed in an adapter
as discussed below. This reduces the size of the dispenser.
Alternatively, the interface can comprise a wireless interface,
such as an inductive loop or a rf link that could be powered by
induced rf power.
[0027] A dispenser in accordance with the present invention can
also include a tilt sensor. By way of example, common tilt sensors
include mercury switches, sonic sensors, and capacitive sensors.
Since the dispensing container is sealed and isolated from the
monitor electronics, there is no risk of contamination of the
medicinal fluid or other potential risk to the patient, e.g., from
mercury. If included in a dispenser, this switch would be connected
to connectors 52 shown in FIG. 4. As an example, the mercury switch
closes a connection (connected to connectors 52) when the dispenser
bottle is inverted within .+-.15.degree. from fully inverted
(vertical) position. Transitions to and from vertical move the
microcontroller 45 from its power down or sleep mode to its active
mode which remains independent of bottle position for some time,
for example 3 minutes, after activation. This insures that when the
dispenser is inverted, the system does not repetitively activate
and de-activate. Instead, the system remains active until the
bottle is turned upright, goes to sleep, and then waits for the
next inversion. There is provision for the circuits to de-activate
when the dispenser remains inverted over a certain short period of
time; thus preventing power drain if the dispenser remains off the
vertical position when stored.
[0028] FIG. 5 is a flow diagram of software for an exemplary
embodiment of the invention. The software can be stored in a memory
within the microcontroller 45, or can be stored external to the
microcontroller 45, depending upon the particular component used as
the microcontroller 45. Referring to FIG. 5, the software begins at
step 85 when power is applied to the system, such as by installing
a battery (discussed below) in the system. In the example of a
medical dispenser this power up could occur in a physician's or
pharmacist's office. At step 90 the system waits to allow the
bottle to be stabilized, such as being set in a communications
adapter. The date and time can be recorded at step 95, followed by
the system testing the adapter base connection at step 100. As will
be appreciated by those skilled in the art, such a test could
comprise activating a request-to-send signal and waiting for a
clear-to-send signal. In step 105, if the clear-to-send signal is
received, the dispenser is still in the adapter base and processing
returns to step 90. If, however, the clear-to-send signal is not
received, then processing continues to step 110. Here it is assumed
that the dispenser has been removed from the adapter base and
delivered to the user. Consequently, step 110 records the delivery
time and date. The microcontroller 45 then goes into its power down
or sleep mode in step 115.
[0029] FIG. 5 also illustrates the program logic for a dispenser
that includes an optional tilt sensor, and downloading recorded
data. With the optional tilt sensor, tilting the dispenser causes
the tilt sensor to sense the tilt of the dispenser. This event is
sensed at step 160 and wakes the microcontroller 45 (step 130). The
microcontroller 45 monitors, for example, the communications
interface 80 to determine if it has been inserted into the adapter
base at step 132. This monitoring can be in a manner similar to
that described with respect to step 105. If the microcontroller 45
has been inserted the data is downloaded via RS-232 to a computer
at step 134. Next, the microcontroller 45 tests for the presence of
the top 25 in step 135. As an example, the microcontroller 45 can
test the frequency of an LC oscillator that includes coil 20.
Depending upon the location of the top 25, the oscillator will have
a different inductance, thus a different frequency. The
microcontroller 45 can count the time elapsed for a period of the
oscillator to detect the frequency of the oscillator.
[0030] In step 140, the microcontroller 45 tests for the presence
of the top 25. If the top 25 is not removed, the computer returns
to step 115 and to its sleep mode of operation. If the dispenser
top 25 has been removed, microcontroller 45 records the time at
step 145. The time can be just the month, day and current time if
the year was stored at step 95. Otherwise, the time would include
the year. The time can be stored in EEPROM memory 60 shown in FIG.
4. If the dispenser were used as a medication dispenser, this time
would constitute the time that the user begins to dispense the
medication. The microcontroller 45 then waits at step 150 before
testing the tilt sensor in step 155. If the dispenser is still
tilted as sampled in step 160, the microcontroller 45 continues the
waiting and testing steps 150 and 155. If, however, the dispenser
is no longer tilted, the microcontroller 45 records the time at
step 165. Again, if the dispenser were used as a medication
dispenser, this time would constitute the time that the user
finishes dispensing the medication. Again, this time can be stored
in EEPROM memory 60 shown in FIG. 4. The microcontroller 45 then
returns to step 115 and to its sleep mode of operation.
[0031] FIG. 6 is an exemplary layout of the electrical components
in an embodiment of the invention. In FIG. 6, Y1 and Y2 correspond
to the crystals shown in FIG. 4; SER 5008 identifies a tilt sensor;
SC70 and SOT 23 represent common signal conditioning circuits; and
the three dots at the bottom of the housing 30 represent contacts
for GND, SDA (serial data) and SCK (serial clock). In the
illustrated embodiment, a battery 170 powers the electrical circuit
40. To facilitate a small size for the electrical circuit 40, the
battery 170 is preferably a watch type battery, such as a 3-volt
lithium cell. The battery 170 is mounted on a circuit board 175.
The circuit board 175 can have an induction coil wound on the
surface thereof as part of the interface 75.
[0032] FIG. 7 is an example of adapter connections in an embodiment
of the invention. The bottom of the electronics housing 30 can
include a conductive pattern 180 shown in FIG. 6. As denoted in
FIG. 7, the conductive pattern can be used for ground (GND). The
circular patterns shown in FIG. 7 are the circular contacts for SCK
and SDA in the adapter to mate with the contacts for SCK and SDA on
the bottle which in turn connect to the three beads in FIG. 6. With
circular contacts, the system makes contact no matter which
orientation the bottle is inserted into the adapter. The conductive
pattern 180 electrically mates with corresponding conductors
[0033] FIG. 8 is an example of adapter cabling in an embodiment of
the invention. The adapter cabling shown in FIG. 8 can be used to
connect the adapter to, for example, a personal computer or
personal data assistant. Communications between the electrical
circuit 40 and the personal computer take place via the interface
75. As noted above, the interface 75 can comprise any suitable
communications link, such as a direct connection (FIG. 7) or via an
inductive coil. Use of an inductive coil allows the microcontroller
45 to communicate with, for example, a personal computer without
the need for electrical contacts on the electronics housing 30.
[0034] As an additional element, a dispenser in accordance with the
present invention can also include a pressure sensor. The pressure
sensor is a thin flexible film that can be formed to function as
the label 35 or be placed (hidden) between the label inside and the
dispenser outside surfaces. It will detect minute pressure changes
from the patient squeezing on the dispenser and will only operate
when the dispenser has been inverted and the top 25 has been
removed. As those skilled in the art will recognize, the
microcontroller 45 can monitor the amount of pressure and relate it
to the amount of medication delivered. The pressure sensor can be
either a piezoelectric, capacitive, or a polymer/carbon resistance
sensor. Either sensor is only approximate 1-2-5 mils thick and
therefore would be inconspicuous. When the top 25 has been removed
and the clock 55 awakened, the microcontroller 45 can monitor the
state of the pressure sensor. The microcontroller 45 could also use
the pressure sensor to determine the duration of the administration
of medication.
* * * * *